Chrysalis Intelligence · Sponsors · William Cook Europe Aps

William Cook Europe Aps

Bjaeverskov, DK · 6 510(k) clearances · 16 PMAs

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Total clearances
6
2021-07-28 → 2025-11-09
Last 12 months
1
Product codes
3
Most recent
2025-11-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DTK Filter, Intravascular, Cardiovascular Class II Cardiovascular 3 2024-01-18
DQX Wire, Guide, Catheter Class II Cardiovascular 2 2025-11-09
BTR — — — 1 2025-06-11
Class III

PMA approvals (16)

Total PMA records
16
Originals + supplements
Distinct product codes
1
First decision
2021-03-31
Most recent
2026-08-04
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-04 P180001-S018 Zenith Dissection Endovascular System (ZDEG/ZDES) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-05-21 P180001-S017 Zenith Fenestrated AAA Endovascular Graft 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-05-08 P180001-S016 Zenith Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-19 P180001-S015 Zenith Dissection Endovascular System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-07-19 P180001-S014 Zenith Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-07-09 P180001-S013 Zenith Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-29 P180001-S012 Zenith Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-12-15 P180001-S010 Zenith® Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-12-14 P180001-S008 Zenith® Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-12-13 P180001-S009 Zenith® Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-07 P180001-S007 Zenith Dissection Endovascular System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-09-01 P180001-S006 Zenith Dissection Endovascular System Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-06-02 P180001-S005 Zenith Dissection Endovascular System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-04-14 P180001-S004 Zenith Dissection Endovascular System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-15 P180001-S003 Zenith® Dissection Endovascular System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-31 P180001-S002 Zenith Dissection Endovascular System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-11-09 K251596 Lunderquist Extra Stiff Wire Guide DQX Class II Cardiovascular
2025-06-11 K251499 Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) BTR — —
2024-01-18 K233680 Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter DTK Class II Cardiovascular
2022-02-17 K220137 Lunderquist Extra Stiff Wire Guide DQX Class II Cardiovascular
2021-07-28 K211875 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach DTK Class II Cardiovascular
2021-07-28 K211874 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach DTK Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence